Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection

NCT05208801 | Completed

• 1 other identifier: 4-2018-0838
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Efficient postoperative pain control plays a vital part in the management of patients after surgery. In particular, major surgeries including hepatectomy cause intense postoperative pain that may result in cardiovascular or respiratory complications post-surgery. One of the current methods of postoperative pain control after hepatectomy involves a multimodal approach including intrathecal morphine injection immediately prior to surgery. Because morphine alone is inadequate for immediate postoperative pain control due to a late peak effect time of 6 hours, current literature advocates a combination injection including bupivacaine. However, higher doses of bupivacaine may inadvertently cause motor block or hemodynamic side effects. The aim of this study was to compare the effectiveness and side effects of intrathecal morphine combined with low dose bupivacaine against intrathecal morphine alone and no intrathecal injection.

Conditions

Patients Receiving Hepatectomy Under General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesic

  Time to first rescue analgesic during the first 72 hours after surgery (hr) was our primary outcome.

  First 72 hours after surgery

Secondary Outcomes (5)

• Pain score after surgery (visual analogue scale, VAS)

  30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit(PACU), 5 hours post surgery, 1 day post-surgery

• Total fentanyl dose administered via intravenous patient-controlled analgesia (PCA)

  First 48 hour post surgery

• Additional rescue analgesics given to the patient

  until 3 days post-surgery.

• Sensory and motor block

  30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit (PACU), 5 hours post surgery, 1 day post-surgery

• Presence of complications (headache, nausea/vomiting, pruritus, respiratory depression, somnolence, low blood pressure, tingling, and shivering)

  first 3 days post surgery

Study Arms (3)

Control

SHAM COMPARATOR

a sham procedure of 2 ml of 1% lidocaine injected percutaneously using the initial 25G needle

Drug: Percutaneous injection

Morphine

ACTIVE COMPARATOR

Drug: Morphine

Morphine+bupivicaine

EXPERIMENTAL

Drug: Morphine+Bupivacaine

Interventions

Percutaneous injection DRUG

A sham procedure of 2 ml of 1% lidocaine injected percutaneously using the initial 25G needle for local anesthetics

Control

Morphine DRUG

Intrathecal injection of morphine 400mcg

Morphine

Morphine+Bupivacaine DRUG

Intrathecal injection of 5mg of 0.5% bupivacaine chloride

Morphine+bupivicaine

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years to no upper limit
• Patients receiving liver resection under general anesthesia (Including open surgery and laparoscopic surgery)
• American Society of Anesthesiologists (ASA) physical status 1,2

You may not qualify if:

• Patients presenting with coagulopathy prior to surgery
• Patients with neurological deficits
• Patients with spinal anomaly or disorders
• Patients with allergies to opioids or local anesthetics
• Patients with severe respiratory, cardiovascular, renal, or hepatic disorders
• Severe systemic infection or infections involving proposed intrathecal injection site
• Patients with severe psychological disorders severe that may interfere with pain evaluation
• Patients with chronic diseases that require opioids

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Administration, Cutaneous; Morphine

Intervention Hierarchy (Ancestors)

Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Bon-Nye Koo

  Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 26, 2022
• Study Start: November 19, 2018
• Primary Completion: April 18, 2020
• Study Completion: April 18, 2020
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

KR (1)